The steady expansion and diversification of the health-care industry has led in many regards to a corresponding expansion in the depth, detail and sophistication of regulatory and other reporting requirements which health-care providers face. Hospitals, research institutions and other clinical or medical facilities must consider and satisfy an array of government and industry reporting criteria, including those imposed or applied by the Centers for Medicare and Medicaid Services (CMS), the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), and other public, private, federal, state and other agencies or bodies. Those regulatory or reporting criteria may be required for a variety of purposes, including for purposes of public or private bill payment or reimbursement, professional or clinical accreditation, disease surveillance, census and other purposes. Many of those criteria may be legally mandated, for instance to ensure adherence to best practices and other purposes, and those mandates may change over time. In other cases, the amount or percentage of medical bills which CMS or other payors may agree to pay may depend upon the overall clinical outcomes and documented care delivered by a hospital or other institution.
However, compliance officers and others with regulatory reporting responsibilities may discover that their institutions lack appropriate tools to timely and thoroughly meet the complex regulatory requirements they are charged with satisfying. For example, CMS and other criteria may require that patients with certain classes of diseases or conditions have various blood test, imaging, electrocardiograph and other clinical or medical documentation to have the costs for their medical services reimbursed or paid by Medicare or other plans.
However, many hospitals and other clinical sites lack a ready way to produce that type of clinical data backup for all but the most rudimentary or incomplete data. In many cases, the hospital may rely on the internal patient accounting system, which may be built for billing purposes rather than to track the diverse, rich set of clinical information necessary for all phases of compliance. Thus when a CMS, JCAHO or other requirement calls for documentation that a patient's pneumonia or other diagnosis and treatment was supported by blood gas readings within a certain range, or the ratio of blood readings to other data such as patient population, age brackets or others, the account records may not, and typically do not, contain the clinical data to a sufficient level of detail to meet the requirement.
Moreover, by the time that regulatory compliance is performed, in many settings it may be one or two months or more after the clinical encounter occurred. Retrospectively examining patient accounting records in a period of time after the patient care was delivered often results in no useable data for compliance purposes, at all. Therefore compliance personnel may be forced to have patient charts and other electronic or paper records examined manually, to determine adherence to the regulatory criteria. Besides being time-consuming and prone to human error, certain pieces of data which are called for by the regulatory or other standards body may not exist in any form, after some amount of time after care. Or, that data may not have been captured at any point in the patient's treatment, since patient accounting and other systems used for the ad hoc purpose of acting as a compliance data store may not require, include or condition inputs on compliance requirements. In those and other cases reporting compliance, or the accuracy or completeness of that reporting, can not be ensured. These and other problems in clinical data capture and reporting systems exist.